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Pharmaceutical industry

Cytokinetics Delivers Clinical Trials Data for CK-1827452 to Amgen, Paving Way for Potential Acquisition

Strategic Insights

— 2 min read

Cytokinetics, a biopharmaceutical company focused on muscle contractility, announced the delivery of clinical trials data for its novel cardiac myosin activator, CK-1827452, to Amgen, Inc. The data, which includes results from Phase I and IIa clinical trials, is expected to inform Amgen's decision to exercise its option to acquire an exclusive license to develop and commercialize CK-1827452 worldwide, excluding Japan. CK-1827452 is being developed for the potential treatment of patients hospitalized for heart failure and outpatients with chronic heart failure.

Key Takeaways:

  • Cytokinetics delivered clinical trials data for CK-1827452 to Amgen, which may inform Amgen's decision to exercise its option to acquire an exclusive license to develop and commercialize the drug candidate.
  • The data includes results from Phase I and IIa clinical trials, demonstrating the safety, tolerability, pharmacodynamics, and pharmacokinetic profile of CK-1827452 in patients with heart failure.
  • If Amgen exercises its option, it would be responsible for the development and commercialization of CK-1827452, subject to Cytokinetics' development and commercialization participation rights.
  • Cytokinetics would be eligible to receive pre-commercialization and commercialization milestone payments of up to $600 million, as well as royalties that escalate based on increasing levels of annual net sales of products commercialized under the agreement.
  • The clinical trials data have shown statistically significant increases in systolic ejection time, stroke volume, and ejection fraction at plasma concentrations greater than 100 ng/mL, 200 ng/mL, and 300 ng/mL, respectively.
  • Cytokinetics' cancer program is focused on mitotic kinesins, a family of motor proteins essential to cell division, and the company has two drug candidates targeting this area, ispinesib and SB-743921.
  • Cytokinetics has a collaboration and option agreement with Amgen for CK-1827452, under which Amgen received an option to obtain an exclusive license to develop and commercialize the drug candidate worldwide, except in Japan.

Statistics:

  • Cytokinetics has received approximately $75 million from Amgen, comprised of a non-refundable up-front license and technology access fee of $42 million and an equity investment of approximately $33 million.
  • The exercise fee for Amgen to exercise its option is $50 million, which must be paid within the defined option exercise period.
  • If Amgen exercises its option, Cytokinetics will be eligible to receive pre-commercialization and commercialization milestone payments of up to $600 million.
  • The clinical trials data have shown statistically significant correlations between increasing CK-1827452 plasma concentration and increases in systolic ejection time, stroke volume, and ejection fraction.

Sources:

  • Cytokinetics, Inc. Press Release, February 25, 2009.
  • Market Wire, February 25, 2009.
  • Comtex SmarTrend Alert, February 21, 2009.
  • Cytokinetics, Inc. Investor Presentation, 2008.
  • Amgen Inc. and Cytokinetics, Inc. Collaboration and Option Agreement, 2007.

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